Lockout connector arrangement for implantable medical device

ABSTRACT

A lockout connector arrangement for implantable medical devices having at least one port for receiving a non-cardiac lead connector selectively permits only certain electrical leads to be connected to the implantable medical device. A lead connector pin of a non-cardiac lead connector is specially designed to be larger than a DF-1 lead connector pin, but smaller than an IS-1 lead connector pin. A corresponding header of implantable pulse generator has a connector port for a non-cardiac lead with a proximal-most portion that is larger than the DF-1 lead connector pin, but smaller than the IS-1 lead connector pin; and otherwise generally consistent with the other dimensions of an ISO standard IS-1 pacemaker lead connector.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 11/168,238 (Attorney Docket No.: 001410US), filed Jun. 27,2005, which claims the benefit of U.S. Patent Application Ser. No.60/584,647 (Attorney Docket No. 021433-001400US), filed Jun. 30, 2005,the full disclosures of which are incorporated herein by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

This invention relates to implantable electrical medical devices used tostimulate the heart, other tissue, and nerves, to control thefunctioning of the particular organ or bodily function. Moreparticularly, the present invention is directed to electrical leadconnector arrangements for implantable medical devices that selectivelypermit only certain electrical leads to be connected to the implantablemedical device.

2. Background of the Invention

Implantable pulse generator medical devices are well known in the art,and include medical devices such as pacemakers, defibrillators,baroreflex activation devices and muscle and nerve stimulators.Generally, these medical electrical devices comprise an implantablepulse generator unit and an electrical lead or leads connected to one ormore electrodes. The electrode may be placed adjacent to a particularpart of the human body, such as within the myocardial tissue of theheart, within a vein or proximate any other tissue to be stimulatedand/or sensed. The electrode, which is attached at the distal end of thelead, is attached to the appropriate location in the human body, and theproximal end of the lead is connected to a lead connector assembly ofthe implantable pulse generator. The lead connector assembly, sometimesreferred to as a header, enables the lead to be mechanically andelectrically connected to circuitry within the implantable pulsegenerator.

The header of an implantable pulse generator typically has a pluralityof connector ports to which a plurality of leads may be connected. Forpacemakers and defibrillators, these connector ports are either highvoltage ports for receiving high voltage electrical lead connectors of adefibrillation electrode or low voltage connector ports for receivingelectrical lead connectors of a sensing/pacing electrode. For othertypes of tissue stimulation devices, the connector ports are typicallylow or moderate voltage connector ports for receiving electrical leadconnectors to connect to tissue sensing and/or stimulation electrodes.

For implantable pulse generators having a plurality of ports and aplurality of leads, it is possible for a particular lead to be insertedinto an improper port. If this were to happen, the delivery ofstimulation pulses through an improperly connected lead would notprovide the intended therapy and could be potentially damaging or fatalto a patient. A non-cardiac stimulation lead connected to a pacing portwould likely deliver an ineffective therapy, and could even have thedramatic consequence of inducing fibrillation in the patient; however,the non-cardiac stimulation lead most likely would not be damaged due tothe relatively low voltage of the pacing stimulation pulses. Apotentially more dangerous situation would arise if a low or moderatevoltage lead were to be connected to a connector port for a high voltagedefibrillation electrode. Not only would the unintended delivery of ahigh voltage defibrillation shock of up to 750 V through a pacing orstimulation electrode designed for voltages of less than 5 V likelycause damage to that low or moderate voltage electrical lead, theconsequences for the unintended delivery of such a shock could bedamaging or even fatal to a patient, even if fibrillation were notinduced as a result of the shock.

To prevent defibrillator leads and pacer leads from being connected tothe improper port, the International Standards Organization (ISO)developed standards for the pacer lead connector and the pacer port orcavity, as well as standards for the defibrillator lead connector anddefibrillator port or cavity. The standard for the defibrillatorconnector and cavity is ISO 11318 and the standard for the pacemakerconnector and cavity is ISO 5841-3, both of which are incorporatedherein by reference. The standard pacer port is referred to as an IS-1port and the standard defibrillator port is referred to as a DF-1 port.If the ISO standards are followed for these structures, then a lead madein accordance with one of the standards cannot be connected to a portconstructed in accordance with the other of the standards. Hence, apacer lead made according to the ISO standard (5841-3) will not be ableto be connected to a defibrillator lead connector that was madeaccording to the ISO standard (11318). The details of these ISOstandards are hereby incorporated by reference.

Although the ISO standards provide guidance for defibrillators andpacers to ensure that the lead connectors cannot be operably connectedto the improper port in these two types of implantable medical devices,the problem of how to avoid similar improper connections for other typesof tissue stimulation leads is not addressed.

U.S. Pat. No. 6,044,302 describes a multiport header arrangement for acardiac rhythm management device includes at least one standard port anda separate port for a left ventricular access lead. The left ventricularaccess lead can only be electrically and mechanically coupled to theproper port. Standard IS-1 and DF-1 leads cannot be electrically ormechanically coupled to the port for the left ventricular access lead.The lockout solution described in this patent requires the leftventricular access lead to have a smaller diameter than either the IS-1or DF-1 leads so that the larger leads will not fit in the smallerconnector port. The patent requires the physician to realize that thesmaller left ventricular access lead has been improperly inserted into alarger IS-1 or DF-1 port because of the difficulty in locking down thesmaller diameter lead connector with a set screw that secure the leadconnector into the port.

U.S. Pat. No. 6,705,900 describes an improved connection system forcoupling a device such as a pacemaker, cardioverter, defibrillator,nerve stimulator, muscle stimulator, implantable monitor or othermedical device to a medical lead that features a coupling member, whichincludes an inner lumen sized to form a press fit around the proximalend of the lead body and has connector means to enable a connector pinat the proximal end of the lead to mechanically and electrically coupleto a device. While this system provides a solution for adapting one typeof lead to be used in a different type of connector port, it does notprovide a solution to the problem of improperly inserting one type oflead in a different type of connector port.

Although existing standards have worked well for addressing the problemsof proper connection of leads to implantable pulse generators forcardiac stimulation devices, there is a need for a more general solutionfor addressing the problems of proper connection of leads to implantablepulse generators for other types of tissue stimulation devices.

BRIEF SUMMARY OF THE INVENTION

The present invention is a lockout connector arrangement for implantablemedical devices having at least one port for receiving a non-cardiaclead connector that selectively permits only certain electrical leads tobe connected to the implantable medical device. Specifically, a leadconnector pin of a non-cardiac lead connector is specially designed tobe larger than the lead connector pin of a DF-1 defibrillation leadconnector port, but smaller than the lead connector pin of an IS-1pacemaker lead connector port. A corresponding header is provided for animplantable pulse generator in which a connector port for a non-cardiaclead has a proximal-most portion that is larger than the lead connectorpin of a DF-1 defibrillation lead, but smaller than the lead connectorpin of an IS-1 pacemaker lead. While providing for effective lockoutoperation, the overall dimensions of the remainder of the lead connectorof a preferred embodiment of the present invention remain generallyconsistent with the IS-1 standards to permit the non-cardiac connectorport and connectors to be manufactured with minimal changes to existingheader and lead designs.

As a result of the design of the connector arrangement of the presentinvention, the non-cardiac lead cannot be mechanically or electricallyconnected to a DF-1 defibrillation port, thus effectively barring thepotential harm that could be done if a high-energy defibrillation pulsewere delivered to a non-cardiac lead. Conversely, a DF-1 defibrillationlead cannot be inadvertently electrically connected to a non-cardiacport on the implantable pulse generator. While an IS-1 pacemaker leadcould be mechanically inserted into the non-cardiac lead port of aheader for an implantable pulse generator in accordance with the presentinvention, the electrical contact arrangement within the non-cardiaclead port prevents any inadvertent electrical connection from beingeffectively made. Conversely, the non-cardiac stimulation lead pincannot make effective electrical connection with an IS-1 pacemaker leadport. Thus, the potential harm caused by a tissue stimulation therapypulse being delivered to cardiac tissue through a pacing lead that usesan IS-1 standard, or a pacing stimulation therapy pulse being deliveredto a non-cardiac lead, is effectively obviated.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a medical electrical implantable pulsegenerator and associated electrical leads.

FIG. 2 is a cross-sectional view of the IS-1 pacemaker lead connectorthat meets the ISO 5841-3 standard.

FIG. 3 is a cross-sectional view of the IS-1 pacemaker lead connectorport that meets the ISO 5841 standard.

FIG. 4 is a cross-sectional view of the DF-1 defibrillator leadconnector that meets the ISO 11318:2002 standard.

FIG. 5 is a cross-sectional view of the DF-1 defibrillator leadconnector port that meets the ISO 11318:2002 standard.

FIG. 6 is a cross-sectional view of the non-cardiac lead connector inaccordance with the present invention.

FIG. 7 is a cross-sectional view of the non-cardiac lead connector portin accordance with the present invention that interfaces with thenon-cardiac lead connector as shown in FIG. 6.

DETAILED DESCRIPTION OF THE INVENTION

An implantable pulse generator device typically includes an electricalmedical device such as a pacemaker, cardioverter, defibrillator,baroreflex activation device, nerve stimulator, muscle stimulator,implantable monitor or other medical device and one or more electricalleads. Typically, the pulse generator device comprises a case and aheader attached to the case. The case typically contains the electronicsand the power source (usually a battery) for the implantable pulsegenerator. The leads are connected to the implantable pulse generatorthrough ports in the header.

Referring to FIG. 1, there is shown an implantable pulse generatordevice 10 that is comprised of a header 20 and a case 22 containing apower source 24 and electronics 26. The header portion 20 of theimplantable pulse generator device 10 is typically formed of a moldedthermoplastic material, such as an acrylic material, and includes aplurality of ports 50 (pacing), 70 (defibrillation), and 90(non-cardiac). While the number of ports shown in this embodiment isthree, a greater or lesser number of ports is contemplated by the scopeof the present invention. Each port 50, 70, 90 includes a correspondingorifice 51, 71, 91, which is the entry point to the port 50, 70, 90 andthe interior of the header 20. Electrical leads 30, 32 connect theimplantable pulse generator device 10 to electrodes 34, 36 typicallylocated at their distal end that are positioned proximate a particularlocation in the body to be stimulated or sensed. The electrical leads30, 32 are connected to the header 20 through the appropriate orifice51, 71, 91 of the corresponding port 50, 70, 90 by way of a leadconnector 40, 60 or 80. As will be described, a given lead connector 40,60, 80 is designed to be inserted into a corresponding one of the ports50, 70, 90 and mechanically and electrically couples the associated lead30, 32 with the header 20.

The electrical leads may be cardiac leads 30 designed in accordance witheither the IS-1 or DF-1 standard, or other types of cardiac leads 30,such as the left ventricular lead described in U.S. Pat. No. 6,044,302,or may be non-cardiac leads 32 that are intended for stimulation and/orsensing of tissue or organs other than the heart. In a preferredembodiment of the present invention, the non-cardiac lead connector andlead connector port are adapted for a non-cardiac lead 32 that includesa non-cardiac stimulation electrode 36. One such example of anon-cardiac stimulation electrode is a baroreflex activation lead andelectrode for baroreflex activation, such as shown in U.S. Pat. No.6,522,926 and U.S. Publ. Appl. Nos. 2003/0060857A1 and 2004/0010303A1,the disclosures of which are hereby incorporated by reference.Alternatively, the non-cardiac lead connector and lead connector port ofthe present invention may be utilized for any non-cardiac stimulationapplication, such as nerve, muscle or other tissue or organ stimulation.

FIG. 2 is a cross-sectional view of the pacemaker lead connector 40 thatmeets the ISO 5841-3 standard. The lead connector 40 for the cardiaclead 30 comprises a lead connector body 42 and a lead connector pin 44.The lead connector pin 44 is located at the proximal end of the leadconnector 40 and, when locked in place in the port 50, forms amechanical and physical connection between the lead connector 40 and theheader 20. The lead connector pin 44 is made of conductive material.

The lead connector body 42 has a number of different diameters, as thelead connector body 42 tapers towards the lead connector pin 44. Thediameter 40 d ₁, of the lead connector body 42 proximate the lead is3.1+/−0.3 millimeters. The diameter of the main section of the leadconnector body 42, 40 d ₂, is 3.23+/−0.1 millimeters. This section ofthe lead connector body 42 extends up to the first shoulder 46, where atleast one sealing ring 47 is located. At the first shoulder 46, the leadconnector body 42 tapers to a diameter 40 d ₃ of 2.66+/−0.03 millimetersto 2.66+/−0.05 millimeters. A second sealing area with at least onesealing ring 48 precedes the second shoulder 49 of the lead connectorbody 42. At the second shoulder 49, the lead connector body 42 tapersagain such that the lead connector pin 44 is formed with a diameter 40 d₄ of 1.59+/−0.03 millimeters. The lead connector pin 44 forms theelectrical connection between the lead and the header 20.

The connector port or cavity 50 that is designed to fit with thepacemaker lead connector 40 is shown in FIG. 3. In one embodiment, thepacemaker lead connector port 50 also meets the requirement of ISO5841-3 and is referred to as an IS-1 port. The lead connector port 50has an orifice 25 that provides access for the lead connector 40 intothe lead connector port 50. The lead connector port has a main body 52with a diameter 50 d ₁ of 3.15+/−0.15 millimeters that, at the sealingring zone 57 is 50 d ₂ 3.48+/−0.05 millimeters. Just past the sealingring zone 57 the first shoulder 56 of the lead connector port 50 isformed. The lead connector port 50 tapers at the first shoulder 56 andat the second sealing zone 58, the diameter 50 d ₃ is 2.75+/−0.03millimeters. Following the second sealing zone 58, a second shoulder 59is formed in the lead connector port 50, proximate the lead connectorpin port 54. The lead connector port 50 tapers again to form the leadconnector pin port 54 that has a minimum diameter 50 d ₄ of 1.65millimeters. Hence, the lead connector pin 44 of the pacemaker leadconnector 40 fits through the lead connector pin port 54, allowing forthe lead connector pin 44 to form a mechanical and electrical connectionwith the header 20.

FIG. 4 is a cross-sectional view of the defibrillator lead connector 60that meets the ISO 11318:2002 standard. The lead connector 60 for thecardiac lead 30 comprises a lead connector body 62 and a lead connectorpin 64. The lead connector pin 64 is located at the proximal end of thelead connector 60 and, when locked in place in the port 70, forms amechanical and physical connection between the lead connector 60 and theheader 20. The lead connector pin 64 is made of conductive material.

The lead connector body 62 has a number of different diameters, as thelead connector body 62 tapers towards the lead connector pin 64. Thediameter 60 d ₁ of the lead connector body 62 proximate the lead is3.23+/−0.1 millimeters. The diameter of the main section of the leadconnector body 62, 60 d ₂ is 3.23+0.1, −0.2 millimeters. This section ofthe lead connector body 62 extends up to the first shoulder 66, where atleast one sealing ring 67 is located. At the first shoulder 66, the leadconnector body 62 tapers slightly and then expands to accommodate the atleast one sealing ring to a diameter 60 d ₃ of 3.36+/−0.01 millimeters.A second sealing area with at least one sealing ring 68 precedes thesecond shoulder 69 of the lead connector body 62. At the second shoulder69, the lead connector body 62 tapers again such that the lead connectorpin 64 is formed with a diameter 60 d ₄ of 1.25+/−0.03 millimeters. Thelead connector pin 64 forms the electrical connection between the leadand the header 20.

The connector port or cavity 70 that is designed to fit with thedefibrillator lead connector 60 is shown in FIG. 5. In one embodiment,the defibrillator lead connector port 70 also meets the requirement ofISO 11318:2002(E) and is referred to as a DF-1 port. The lead connectorport 70 has an orifice 25 that provides access for the lead connector 60into the lead connector port 70. The lead connector port 70 has a mainbody 72 with a minimum diameter 70 d ₁ of 3.43+/−0.15 millimeters that,at the sealing ring zone 77 is 70 d ₂ 3.48+/−0.05 millimeters. Just pastthe sealing ring zone 77 the first shoulder 76 of the lead connectorport 70 is formed. The lead connector port 70 tapers at the firstshoulder 76. However, just prior to the first shoulder 76, and at thesecond sealing zone 78, the diameter 70 d ₃ is 3.5+/−0.25 millimeters.Following the second sealing zone 78, the first shoulder 76 is formed inthe lead connector port 70, proximate the lead connector pin port 74.The lead connector port 70 tapers to form the lead connector pin port 74that has a diameter 70 d ₄ of 1.31 millimeters. Hence, the leadconnector pin 64 of the defibrillator lead connector 60 fits through thelead connector pin port 74, allowing for the lead connector pin 64 toform a mechanical and electrical connection with the header 20.

FIG. 6 is a cross-sectional view of a preferred embodiment of anon-cardiac lead connector 80 for a non-cardiac lead 32. The non-cardiaclead connector 80 comprises a lead connector body 82 and a leadconnector pin 84. The lead connector pin 84 is located at the proximalend of the lead connector 80 and, when locked in place in thenon-cardiac lead port 90, forms a mechanical and physical connectionbetween the non-cardiac lead connector 80 and the header 20. The leadconnector pin 84 is made of conductive material.

The lead connector body 82 has a number of different diameters, as thelead connector body 82 tapers towards the lead connector pin 84. Thediameter 80 d ₁ of the lead connector body 82 proximate the lead is3.1+/−0.3 millimeters. The diameter of the main section of the leadconnector body 82, 80 d ₂ is 3.23+/−0.1 millimeters. This section of thelead connector body 82 extends up to the first shoulder 86, where atleast one sealing ring 87 is located. At the first shoulder 86, the leadconnector body 82 tapers to a diameter 80 d ₃ of 2.66+/−0.03 millimetersto 2.66+/−0.05 millimeters. A second sealing area with at least onesealing ring 88 precedes the second shoulder 89 of the lead connectorbody 82. At the second shoulder 89, the lead connector body 82 tapersagain such that the lead connector pin 84 is formed with a diameter 80 d₄ of 1.410+/−0.013 millimeters. The lead connector pin 84 forms theelectrical connection between the lead and the header 20. As will beseen from a comparison of the lead connector body 82 of the non-cardiaclead 32 with the lead connector body 42 of the pacemaker IS-1 lead 30,all of the other dimensions up to the lead connector pin 84 aregenerally consistent with the dimensions of the IS-1 lead connector body42.

The non-cardiac lead connector port or cavity 90 that is designed to fitwith the non-cardiac lead connector 80 is shown in FIG. 7. Thenon-cardiac lead connector port 90 has an orifice 91 that providesaccess for the lead connector 80 into the lead connector port 90. Thelead connector port 90 has a main body 92 with a diameter 90 d ₁ of3.15+/−0.15 millimeters that, at the sealing ring zone 97 is 90 d ₂3.48+/−0.05 millimeters. Just past the sealing ring zone 97 the firstshoulder 96 of the lead connector port 90 is formed. The lead connectorport 90 tapers at the first shoulder 96 and at the second sealing zone98, where the diameter 90 d ₃ is 2.75+/−0.03 millimeters. Following thesecond sealing zone 98, a second shoulder 99 is formed in the leadconnector port 90, proximate the lead connector pin port 94. The leadconnector port 90 tapers again to form the lead connector pin port 94that has a diameter 90 d ₄ of 1.50+/−0.02 millimeters. Hence, the leadconnector pin 84 of the non-cardiac lead connector 80 fits through thelead connector pin port 94, allowing for the lead connector pin 94 toform a mechanical and electrical connection with the header 20.

The non-cardiac lead connector pin 84 has been designed to have adiameter that is intermediate the defibrillator (DF-1) lead connectorpin diameter and the pacemaker (IS-1) lead connector pin diameter. Theranges of diameters for lead connector pins and lead connector pin portsfor the defibrillation lead (DF-1), the pacemaker lead (IS-1) and apreferred embodiment of a non-cardiac lead are provided in Table 1.TABLE 1 LEAD CONNECTOR LEAD CONNECTOR PIN PORT PIN DIAMETER DIAMETER(mm) (mm) DEFIBRILLATOR DF-1 1.25 ± 0.03 1.31 PACEMAKER IS-1 1.59 ± 0.031.65 minimum NON-CARDIAC (e.g., 1.410 ± 0.013 1.50 ± 0.02 BAROREFLEXACTIVATION DEVICE)

An advantage derived from the design of the non-cardiac lead connector80 and corresponding port 90 is that an effective lockout connectorarrangement is provided between the non-cardiac lead 32 and anystandardized cardiac leads 30 for the implantable medical devices notedabove. Due to the size of the diameter of the non-cardiac lead connectorpin 84, the non-cardiac lead 32 cannot be mated with the defibrillatorlead connector pin port 70. Since this connection is prevented, thepossibility of high-energy defibrillation pulses inducing localizedtissue damage, or worse trauma, is effectively eliminated. Anotheradvantage derived from the configuration of the non-cardiac leadconnector 80 and the corresponding port 90 is that the pacemaker leadconnector (IS-1) pin 44 cannot be operably coupled with the non-cardiaclead connector pin port 94. Hence, the possibility of baroreflexactivation therapies, for example, causing harm because they weredelivered to cardiac tissue through a pacing lead (IS-1) also has beeneffectively eliminated as a result of the design in accordance with thepresent invention.

While the present invention has been described with respect toparticular standards for the cardiac leads 30 and to one embodiment of anon-cardiac lead 32 for baroreflex activation proximate the carotidsinus, it is to be understood that variations in the present inventioncan be made without departing from the novel aspects of this inventionas defined in the claims. For example, it is not necessary for animplantable pulse generator to have one or both of connector ports 50(pacing) and 70 (defibrillation), such as in the case where theimplantable pulse generator is solely designed for non-cardiacstimulation/sensing purposes. Alternatively, an implantable pulsegenerator which combined one or both of pacing and defibrillationtherapies with a non-cardiac therapy, such as nerve stimulation, wouldhave one or both of the connector ports (50) and 70 (defibrillation) inconjunction with the non-cardiac port 90 in accordance with the presentinvention.

1. A kit, comprising: an implantable medical device having a header; theheader comprising at least one cardiac port and at least one non-cardiacport; at least one cardiac electrode, each cardiac electrode beingelectrically connected to a cardiac connector; at least one non-cardiacelectrode, each non-cardiac electrode being electrically connected to anon-cardiac connector; wherein the at least one non-cardiac port willnot form a functional connection with the cardiac connector; and whereinthe at least one cardiac port will not form a functional connection withthe non-cardiac connector.
 2. The kit of claim 1, wherein: wherein theat least one non-cardiac port will not receive the cardiac connector;and wherein the at least one cardiac port will not receive thenon-cardiac connector.
 3. The kit of claim 1, wherein the at least onecardiac electrode is placed on or in the heart.
 4. The kit of claim 1,wherein the at least one non-cardiac electrode is not placed on or inthe heart.
 5. The kit of claim 1, wherein the at least one non-cardiacconnector comprises a lead connector pin having a diameter larger thanan ISO standard DF-1 defibrillation lead connector pin.
 6. The kit ofclaim 1, wherein the at least one non-cardiac connector comprises a leadconnector pin having a diameter smaller than an ISO standard IS-1pacemaker lead connector pin.
 7. The kit of claim 1, wherein the atleast one non-cardiac port comprises an orifice with a proximal-mostportion having a diameter smaller than an ISO standard IS-1 pacemakerlead connector pin.
 8. The kit of claim 1, wherein the at least onecardiac port comprises an orifice with a proximal-most portion having adiameter smaller than a diameter of a lead connector pin of thenon-cardiac connector.
 9. The kit of claim 1, wherein the at least onenon-cardiac port comprises an orifice with a proximal-most portionhaving a diameter larger than an ISO standard DF-1 defibrillation leadconnector pin.
 10. The kit of claim 1, wherein a lead connector pin ofthe at least one non-cardiac connector has a diameter that issufficiently large to prevent the non-cardiac connector from beingreceived in an ISO standard DF-1 pin socket.
 11. The kit of claim 1,wherein a lead connector pin of the non-cardiac connector has a diametersmaller than 1.56 millimeters.
 12. The kit of claim 1, wherein a leadconnector pin of the non-cardiac connector has a diameter larger than1.31 millimeters.
 13. The kit of claim 1, wherein the non-cardiac porthas a distal diameter small enough to preclude insertion of at leastsome ISO standard DF-1 connector lead bodies.
 14. The kit of claim 1,wherein the non-cardiac port has a proximal diameter small enough topreclude insertion of an ISO standard IS-1 connector pin.
 15. The kit ofclaim 1, wherein the non-cardiac port has a distal diameter smaller than3.21 millimeters.
 16. The kit of claim 1, wherein the non-cardiac porthas a proximal diameter smaller than 1.56 millimeters.
 17. The kit ofclaim 1, wherein the at least one cardiac port comprises a pacing portdimensioned in accordance with ISO-5841-3.
 18. The kit of claim 1,wherein the at least one cardiac port comprises a defibrillation portdimensioned in accordance with ISO-11318.
 19. A system, comprising: animplantable medical device having a header; the header comprising acardiac port and a non-cardiac port; a cardiac connector received in acardiac port of the header; a cardiac electrode electrically connectedto the cardiac connector; a non-cardiac connector received in thenon-cardiac port of the header; a non-cardiac electrode electricallyconnected to a non-cardiac connector; wherein the non-cardiac port willnot form a functional connection with the cardiac connector; and whereinthe cardiac port will not form a functional connection with thenon-cardiac connector.
 20. The system of claim 19, wherein: wherein theat least one non-cardiac port will not receive the cardiac connector;and wherein the at least one cardiac port will not receive thenon-cardiac connector.
 21. The system of claim 19, wherein the at leastone cardiac electrode is placed on or in the heart.
 22. The system ofclaim 19, wherein the at least one non-cardiac electrode is not placedon or in the heart.
 23. The system of claim 19, wherein the non-cardiacconnector comprises a lead connector pin having a diameter larger thanan ISO standard DF-1 defibrillation lead connector pin.
 24. The systemof claim 19, wherein the non-cardiac connector comprises a leadconnector pin having a diameter smaller than an ISO standard IS-1pacemaker lead connector pin.
 25. The system of claim 19, wherein thenon-cardiac port comprises an orifice with a proximal-most portionhaving a diameter smaller than the ISO standard IS-1 pacemaker leadconnector pin.
 26. The system of claim 19, wherein the cardiac portcomprises an orifice with a proximal-most portion having a diametersmaller than a diameter of a lead connector pin of the non-cardiacconnector.
 27. The system of claim 19, wherein the non-cardiac portcomprises an orifice with a proximal-most portion having a diameterlarger than the ISO standard DF-1 defibrillation lead connector pin. 28.The system of claim 19, wherein a lead connector pin of the non-cardiacconnector has a diameter that is sufficiently large to prevent thenon-cardiac connector from being received in an ISO standard DF-1 pinsocket.
 29. The system of claim 19, wherein a lead connector pin of thenon-cardiac connector has a diameter smaller than 1.56 millimeters. 30.The system of claim 19, wherein a lead connector pin of the non-cardiacconnector has a diameter larger than 1.31 millimeters.
 31. The system ofclaim 19, wherein the non-cardiac port has a distal diameter smallenough to preclude insertion of at least some ISO standard DF-1connector lead bodies.
 32. The system of claim 19, wherein thenon-cardiac port has a proximal diameter small enough to precludeinsertion of an ISO standard IS-1 connector pin.
 33. The system of claim19, wherein the non-cardiac port has a distal diameter smaller than 3.21millimeters.
 34. The system of claim 19, wherein the non-cardiac porthas a proximal diameter smaller than 1.56 millimeters.
 35. The system ofclaim 19, wherein the cardiac port comprises a pacing port dimensionedin accordance with ISO-5841-3.
 36. The system of claim 19, wherein thecardiac port comprises a defibrillation port dimensioned in accordancewith ISO-11318.
 37. A method of preventing patient harm or device damagein an implantable medical device including both cardiac and non-cardiacelectrodes, the method comprising: providing one or more cardiacelectrodes, each cardiac electrode being electrically connected to acardiac connector; providing one or more non-cardiac electrodes, eachnon-cardiac electrode being electrically connected to a non-cardiacconnector; providing an implantable medical device including one or morecardiac ports and one or more non-cardiac ports; wherein the one or morenon-cardiac ports will not receive the cardiac connector; and whereinthe one or more cardiac ports will not receive the non-cardiacconnector.